Reviews of Pediatric Studies Conducted under BPCA and PREA from 2012 – present
As required by the Pediatric Research Equity Act of 2012 (PREA), as amended by FDASIA (Public Law 112-144), the following are the medical, statistical, and clinical pharmacology reviews of pediatric studies conducted in response to a Written Request issued under the Best Pharmaceuticals for Children Act (BPCA) and pediatric assessments conducted under PREA.
Total Number of Products Studied under BPCA = 68
Total Number of Products Studied under PREA = 354
Total Number of Products Studied under Both = 13
Find Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies in the FDA Archive
| Drug | Sponsor | Medical Review | Clinical Pharmacology Review | Statistical Review | BPCA or PREA or Both |
|---|---|---|---|---|---|
| Abacavir and Lamivudine - Epzicom | ViiV Healthcare Company | Medical (PDF - 2.8 MB) | Clinical pharmacology (PDF - 158 KB) | Statistical (PDF - 693 KB) | PREA |
| Abacavir, Dolutegravir, and Lamivudine - Triumeq | ViiV Healthcare Company | Medical (PDF - 443 KB) | Clinical pharmacology (PDF - 128 KB) | None | PREA |
| Abacavir sulfate - Ziagen | ViiV Healthcare Company | Medical (PDF - 4.2 M B) | Clinical pharmacology (PDF - 3 MB) | Statistical (PDF - 4.7 MB) | PREA |
| Abatacept - Orencia | Bristol-Myers Squibb Company |
Medical (PDF - 259 KB) Medical Addendum (PDF - 469 KB) |
Clinical pharmacology (PDF - 2.3 MB) Clinical pharmacology (PDF - 269 KB) |
None | BPCA |
| AbobotulinumtoxinA - Dysport | Ipsen Bipharm Limited | CDTL Review (PDF - 2 MB) Medical (PDF - 3 MB) |
None | Statistical (PDF -2 MB) | PREA |
| AbobotulinumtoxinA - Dysport | Ipsen Bipharm Limited | Medical (PDF - 1 MB) | None | Statistical (PDF - 857 KB) | PREA |
| Acetaminophen - Ofirmev | MallInc.krodt, Inc. | Medical (PDF - 1.3 MB) | Clinical pharmacology (PDF - 5.4 MB) | Statistical (PDF -378 KB) | PREA |
| Acyclovir 5%, hydrocortisone 1% - Xerese | Valeant International Bermuda | Medical (PDF -885 KB) | None | None | PREA |
| Acyclovir sodium - Zovirax | GlaxoSmithKline, LLC | None | Clinical pharmacology (PDF - 3 MB) | None | PREA |
| Adalimumab-aqvh - Yusimry NEW | Coherus BioSciences, Inc | Medical (PDF - 5 MB) | None | None | PREA |
| Adalimumab-atto - Amjevita | Amgen Inc. |
CDTL Review (PDF - 4.3 MB) |
Clinical pharmacology (PDF - 3 MB) | Statistical (PDF - 416 KB) Statistical (PDF - 363 KB) Statistical (PDF - 717 KB) |
PREA |
| Adalimumab-fkjp - Hulio | Mylan Pharmaceuticals Inc. | Medical (PDF - 2.2 MB) | None | None | PREA |
| Adalimumab - Humira | AbbVie,Inc. | Medical (PDF - 2.2 MB) | None | None | PREA |
| Adapalene and benzoyl peroxide - Epiduo | Galderma Laboratories, LP | Medical (PDF - 2.2 MB) | Clinical pharmacology (PDF -124 KB) | Statistical (PDF -577 KB) | PREA |
| Adapalene and benzoyl peroxide - Epiduo Forte | Galderma Research and Development LLC | Medical (PDF - 6.2 MB) | Clinical pharmacology (PDF -3.6 MB) | Statistical (PDF -1.6 MB) | PREA |
| Anidulafungin - Eraxis | Vicuron Holdings LLC, a subsidiary of Pfizer Inc. | Medical (PDF - 5 MB) | None | None | PREA |
| Albuterol sulfate - ProAir RespiClick | Teva Pharmaceutical Products R. & D., Inc. | Medical (PDF - 3 MB) | Clinical pharmacology (PDF -4 MB) | Statistical (PDF -2.2 MB) | PREA |
| Albuterol sulfate - ProAir RespiClick | Teva Branded Pharmaceutical Products R&D, Inc. | Medical (PDF - 859 KB) | Clinical pharmacology (PDF -2.5 MB) | Statistical (PDF -1.1 MB) | PREA |
| Aliskiren - Tekturna | Noden Pharma DAC | CDTL (PDF - 310 KB) | Clinical pharmacology (PDF -3.3 MB) | Statistical (PDF - 442 KB) | BPCA |
|
Amlodipine benzoate - Katerzia |
Silvergate Pharmaceuticals, Inc | Medical (PDF - 46 KB) | Clinical pharmacology (PDF - 337 KB) | None |
PREA |
| Amphetamine - Adzenys ER | Neos Therapeutics, Inc. | Medical (PDF - 1.9 MB) | Clinical pharmacology (PDF - 4.1 KB) | None | PREA |
| Amphetamine Extended-Release Orally Disintegrating Tablets - Adzenys XR-ODT | Neos Therapeutics, Inc. | Medical (PDF - 470 KB) | Clinical pharmacology (PDF -3.3 MB) | None | PREA |
| Amphetamine - Dyanavel XR | Tris Pharma | Medical (PDF - 1.8 MB) | Clinical pharmacology (PDF -4.8 MB) | Statistical (PDF -767 KB) | PREA |
| Amphetamine - Dyanavel XR | Tris Pharma |
Medical (PDF - 848 KB) CDTL Review (PDF - 1 MB) |
None | None | PREA |
|
Amphetamine sulfate - Evekeo |
Arbor Pharmaceuticals, LLC |
Medical (PDF - 1 MB) Medical (PDF - 155 KB) |
Clinical pharmacology (PDF - 9 KB) Clinical pharmacology memo (PDF - 9 KB) |
Statistical (PDF - 532 KB) | PREA |
| Aprepitant - Emend | Merck Sharp & Dohme Corp. | Medical (PDF - 5.7 MB) Medical Addendum (PDF -1.1 MB) Medical DD memo (PDF -2.9 MB) |
Clinical pharmacology (PDF -5 MB) Clinical pharmacology addendum (PDF -424 KB) |
Statistical (PDF -1.4 MB) | PREA |
| Aprepitant - Emend | Merck Sharp & Dohme Corp. | Medical (PDF - 553 KB) | Clinical pharmacology (PDF - 5 MB) Addendum (PDF -105KB) |
Statistical (PDF -1.2MB) | PREA |
| Aprepitant - Emend | Merck Sharp & Dohme Corp. |
Medical (PDF - 5 MB) Medical Addendum (PDF -1.1 MB) Medical DD memo (PDF - 2.9 MB) |
Clinical pharmacology (PDF - 5MB) Addendum (PDF - 105KB) |
Statistical (PDF -1.2MB) | PREA |
| Aripiprazole - Abilify | Otsuka | Medical (PDF - 2.4MB) | None | Statistical (PDF -409KB) | PREA |
| Asenapine - Saphris | Forest Laboratories, Inc. | Medical (PDF - 5.4MB) Medical (PDF - 4MB) |
Clinical pharmacology (PDF -3.8MB) | Statistical (PDF -3MB) | BPCA |
| Asparaginase erwinia chrysanthemi (recombinant)- rywn - RYLAZE | Jazz Pharmaceuticals Ireland Limited | Medical (PDF - 4 MB) | None | None | PREAW |
| Atazanavir and cobicistat - Evotaz | Bristol-Myers Squibb Company | CDTL (PDF - 402 KB) | Clinical pharmacology (PDF -1MB) | None | PREA |
| Atazanavir - Reyataz | Bristol-Myers Squibb Company | Medical (PDF - 14.1MB) | Clinical pharmacology (PDF -1MB) | Statistical (PDF -1.9MB) | BOTH |
| Atazanavir - Reyataz | Bristol-Myers Squibb Company | Medical (PDF - 1.6MB) | Clinical pharmacology (PDF -1MB) | Statistical (PDF -3.9MB) | BOTH |
| Atazanavir - Reyataz | Bristol-Myers Squibb Company | Medical (PDF - 461 KB) | Clinical pharmacology (PDF - 318 KB) S | Statistical (PDF - 682 KB) |
BOTH
|
|
Atezolizumab - TECENTRIQ |
Genentech, Inc. | Medical (PDF - 1 MB) | None | None | PREA |
|
Atropine-pralidoxime - DueDote |
Meridian Medical Technologies, Inc. |
CDTL (PDF - 402 KB) Medical (PDF - 886 KB) |
Clinical pharmacology (PDF - 1 MB) | None | PREA |
| Atropine Sulfate - Isopto Atropine 1% | Alcon Research, Ltd. | Medical (PDF - 663KB) | Clinical pharmacology (PDF - 480KB) | Statistical (PDF - 230KB) | PREA |
| Atropine Sulfate Ophthalmic Solution | Akorn, Inc. | Medical (PDF - 1.2 MB) | Clinical pharmacology (PDF - 1MB) | Statistical (PDF - 287KB) | PREA |
| Azelastine hydrochloride - Astepro | Meda Pharmaceuticals | Clinical (PDF -1 .4MB) | None | Statistical (PDF -473 KB | PREA |
| Azelastine hydrochloride - Astepro | Meda Pharmaceuticals Inc. | Medical (PDF - 2MB) | None | None | PREA |
| Azelastine hydrochloride and Fluticasone propionate - Dymista | Meda Pharmaceuticals, Inc. | Medical (PDF - 2.9MB) | None | Statistical (PDF -2.1MB) | BPCA |
| Baclofen - Lyvispah | Saol Therapeutics Research Limited | Medical (PDF - 2 MB) | Clinical pharmacology (PDF - 448 KB) | None | PREA |
|
Baloxavir marboxil - Xofluza |
Shionogi, Incorporated
|
CDTL (PDF - 869 KB) Medical (PDF - 414 KB) |
Clinical pharmacology (PDF - 3 MB) | Statistical (PDF - 2 MB) | PREA |
| Baloxavir marboxil - Xofluza | Genentech, Incorporated | Medical (PDF - 11 MB) | None | None | PREA |
| Barium sulfate - E-Z-HD | Bracco Diagnostics Inc. | Medical (PDF - 2.4MB) | Clinical pharmacology (PDF -642KB) | Statistical (PDF -988KB) | PREA |
| Barium sulfate - READI-CAT 2 & READI-CAT 2 SMOOTHIE | Bracco Diagnostics | Medical (PDF - 2.4MB) | Clinical pharmacology (PDF -702KB) | Statistical (PDF -1.2MB) | PREA |
| Barium sulfate - Varibar Pudding | Bracco Diagnostics, Inc. | Medical (PDF - 1MB) | None | None | PREA |
| Barium sulfate - Liquid E-Z-Paque | Bracco Diagnostics, Inc. | DD Summary Review (PDF - 233 KB) | None | None | PREA |
| Beclomethasone dipropionate - Qnasl | Teva Branded Pharmaceutical Products R&D, Inc. | Medical (PDF - 4 MB) | Clinical pharmacology (PDF -1.5MB) | Statistical (PDF -959KB) | PREA |
|
Belumosudil - Rezurock
|
Kadmon Pharmaceuticals, LLC | Medical (PDF - 7MB) | Non | None | PRE |
| Belimumab - Benlysta | Human Genome Sciences | Medical (PDF - 6 MB) | None | None | PREA |
| Benralizumab - Fasenra | AstraZeneca AB | Medical (PDF - 1.7 MB) | Clinical pharmacology (PDF -7 MB) | Statistical (PDF - 2 MB) | PREA |
| Bictegravir, emtricitabine, and tenofovir alafenamide - Biktarvy | Gilead Sciences, Inc. |
CDTL (PDF - 157 KB) CDTL 1 (PDF - 2 MB) |
Clinical pharmacology (PDF - 2 MB) | None | PREA |
| Bictegravir, emtricitabine, and tenofovir alafenamide - Biktarvy | Gilead Sciences, Inc. | CDTL (PDF - 2 MB) | Clinical pharmacology (PDF - 4 MB) | None | PREA |
| Bimatoprost ophthalmic solution, 0.03% - Latisse | Allergan, Inc. | DD Summary Review (PDF - 966KB) CDTL Review (PDF - 3.4MB) Medical (PDF - 1.6MB) |
None | Statistical (PDF -946KB) Statistical Addendum (PDF - 127KB) |
PREA |
|
Blinatumomab - Blincyto
|
Amgen, Inc. | Medical (PDF - 9 MB) | Clinical pharmacology (PDF -1.2MB) | Statistical (PDF -374KB) | BPCA |
| Bortezomib - Velcade | Millennium Pharmaceuticals, Inc. | Medical (PDF - 3.5MB) | Clinical pharmacology (PDF -1.2MB) | Statistical (PDF -374KB) | BPCA |
| Budesonide - Entocort EC | Elan Pharma International | Medical (PDF - 2.9MB) | Clinical pharmacology (PDF -2.8MB) | Clinical pharmacology (PDF -2.8MB) | PREA |
| Brexpiprazole - Rexulti |
Otsuka Pharmaceutical Company, Ltd. | Medical (PDF - 4 MB) | None | None | PREA |
| Brimonidine tartrate - Lumify | Bausch + Lomb | CDTL Review (PDF - 2.5 MB) Medical (PDF - 556 KB) |
Clinical pharmacology (PDF - 51 KB) | Statistical (PDF - 219 KB) | PREA |
| Brivaracetam - Briviact | UCB, Inc. |
CDTL Review (PDF - 297 KB) Medical (PDF - 1 MB) |
Clinical pharmacology (PDF - 2 MB) | None |
PREA
|
| Brivaracetam - Briviact | UCB, Inc. | Medical (PDF - 74 KB) | Clinical pharmacology (PDF - 2 MB) | None | PREA |
| Budesonide/formoterol fumarate dehydrate - Symbicort | AstraZeneca Pharmaceuticals, LP | Medical (PDF - 3.4 MB) | Clinical pharmacology (PDF - 1.2 MB) | Statistical (PDF - 2.5 MB) | PREA |
| Bupivacaine - Exparel | Pacira Pharmaceuticals, Inc. | Medical (PDF - 6 MB) | Clinical pharmacology (PDF - 2 MB) | None | PREA |
| Buprenorphine - Butrans | Purdue Pharma L.P. | Medical (PDF - 4.1 MB) | Clinical pharmacology (PDF - 1.5 MB) | None | PREA |
| Cabazitaxel - Jevtana | Sanofi-Aventis U.S., L.L.C. | Medical (PDF - 1.5 MB) | Clinical pharmacology (PDF - 1.2 MB) | None | BPCA |
| Calcipotriene - SORILUX Foam | Mayne Pharma LLC | Medical (PDF - 525 KB) | None | None | PREA |
| Calcipotriene - SORILUX | Mayne Pharma LLC | Medical (PDF - 525 KB) | Clinical pharmacology (PDF - 1.2 MB) | None | PREA |
| Calcipotriene and Betamethasone dipropionate - Taclonex | LEO Pharma A/S | Medical (PDF -5.6MB) | Clinical pharmacology (PDF -2.4MB) | Statistical (PDF -564KB) | PREA |
| Calcipotriene and Betamethasone dipropionate - Taclonex | LEO Pharma A/S c/o LEO Pharma, Inc. | Medical (PDF - 3.7MB) | Clinical pharmacology (PDF -2.7MB) | None | PREA |
| Calcipotriene and Betamethasone dipropionate - Taclonex | LEO Pharma A/S | Medical (PDF - 775 KB) | Clinical pharmacology (PDF - 528 KB) | None | PREA |
| Calcipotriene and betamethasone - Enstilar | LEO Pharma A/S | Medical (PDF - 775 KB) | N | None | PREA |
| Calcium Gluconate injection - Calcium Gluconate Injection | Fresenius Kabi USA, LLC |
Medical (PDF - 4 MB) Medical CTDL (PDF - 1.5 MB) |
Clinical pharmacology (PDF - 1 MB) | None | PREA |
| Calcitriol - Vectical |
Galderma Laboratories, L.P. | Medical (PDF - 3 MB) | Clinical pharmacology (PDF - 1 MB) | None | PREA |
| Capecitabine - Xeloda | Hoffmann-La Roche, Inc. | Medical (PDF - 4MB) | Clinical pharmacology (PDF - 1MB) | Statistical (PDF -610KB) | BPCA |
| Carbinoxamine maleate - Karbinal ER | Tris Pharma, Inc. | Medical (PDF - 1.4MB) | Clinical pharmacology (PDF - 500KB) | None | PREA |
| Cefazolin sodium and dextrose solution - Cefazolin for Injection USP and Dextrose Injection USP in the Duplex® Container | B. Braun Medical Inc. | Medical (PDF - 1 MB) | None | None | PREA |
| Ceftaroline fosamil - Teflaro | Cerexa, Inc., A Subsidiary of Forest Laboratories, LLC | Medical (PDF - 10.9MB) Medical CTDL (PDF -1.5MB) |
Clinical pharmacology (PDF - 3MB) | Statistical (PDF -1.2MB) | BPCA |
| Ceftaroline fosamil - Teflaro | Allergan Sales, LLC | Medical (PDF - 5 MB) | None | None | PREA |
| Ceftazidime and Avibactam - Avycaz |
Allergan Sales, LLC | Medical (PDF - 5 MB) | None | None | PREA |
| Cetirizine ophthalmic solution - Zerviate | Nicox Ophthalmics, Inc. |
Medical Resubmission (PDF - 231 KB) Medical (PDF - 4.9 MB) |
Clinical pharmacology (PDF - 279 KB) | Statistical (PDF - 580 KB) | BOTH |
| Cetirizine hydrochloride - Quzyttir | JDP Therapeutics Inc | Medical (PDF - 2 MB) | None | None | PREA |
| Ciclesonide - Zetonna | Takeda GmbH |
Medical (PDF - 5MB) |
Clinical pharmacology (PDF -1.3MB) | Statistical (PDF -674KB) | PREA |
| Cinacalcet hydrochloride - Sensipar |
CDTL (PDF - 2.2 MB) Medical (PDF - 4.1 MB) |
Clinical pharmacology (PDF - 5.6 MB) | Statistical (PDF - 957 KB) | PREA | |
| Ciprofloxacin 0.3% and Fluocinolone acetonide 0.025% - Otovel Otic Solution | Laboratorios SALVAT, S.A. | Medical (PDF - 4MB) | Clinical pharmacology (PDF -632KB) | Statistical (PDF -2MB) | PREA |
| Ciprofloxacin otic suspension - Otiprio | Otonomy, Inc. | Medical (PDF - 233 KB) | Clinical pharmacology (PDF - 79 KB) | Statistical (PDF - 213 MB | PREA |
| 6% Ciprofloxacin Otic Suspension - Otiprio | Otonomy, Inc. | Medical (PDF - 2.3MB) | Clinical pharmacology (PDF -97KB) | Statistical (PDF -896KB) Addendum (PDF -157KB |
PREA |
| Ciprofloxacin ophthalmic solution - Ciloxa | Novartis Pharmaceuticals Corporation |
Medical (PDF - 110 KB) Medical (PDF - 173 KB) |
None | None | BPCA |
|
Clascoterone - Winlevi |
Cassiopea SpA | Medical (PDF - 2.6MB) | None | None | PREA |
| Clonidine - Kapvay | Concordia Pharms Inc. | Medical (PDF - 2.6MB) | None | Statistical (PDF -2MB) | PREA |
| Cobicistat - Tybost | Gilead Sciences, Inc. | CDTL (PDF - 1 MB) | Clinical pharmacology (PDF - 1 MB) | None | PREA |
| Colesevelam HCl - Welchol | Daiichi Sankyo Inc. | CDTL (PDF - 2MB) Medical (PDF - 12MB) |
Clinical pharmacology (PDF - 7MB) | None | PREA |
| Colesevelam HCl - Welchol | Daiichi Sankyo Inc. | Medical (PDF - 3 MB) | None | Statistical (PDF - 308 KB) | PREA |
| Crisaborole Ointment, 2% - Eucrisa | Anacor Pharmaceuticals Inc. | CDTL Review (PDF - 2MB) Medical (PDF - 12MB) |
Clinical pharmacology (PDF - 7MB) | Statistical (PDF - 1MB) | PREA |
| Cysteamine bitartrate - Procysbi | Raptor Pharmaceuticals, Inc. | Medical (PDF -12MB) | Clinical pharmacology (PDF -1.3MB) Clinical pharmacology addendum (PDF -420KB) |
None | BPCA |
| Cysteamine bitartrate - Procysbi | Horizon Pharma USA, Inc. |
Medical (PDF - 2 MB) | Clinical pharmacology (PDF - 1.2MB) | Statistical (PDF - 1MB) | BPCA |
| Dabigatran etexilate - Pradaxa |
Boehringer Ingelheim Pharmaceuticals, Inc. |
Medical (PDF - 2 MB) Medical (PDF - 700 KB) |
Clinical pharmacology (PDF - 5 MB) | None | BPCA |
|
Dalbavancin hydrochloride - Dalvance |
Allergan Sales, LLC | Medical (PDF - 2 MB) | None | None | BPCA |
| Dalteparin sodium - Fragmin | Pharmacia & Upjohn, a subsidiary of Pfizer Inc. | Medical (PDF - 3.5 MB) | None | None | PREA |
| Darunavir, cobicistat, emtricitabine, and tenofovir alafenamide - Symtuza | Jannsen | Medical (PDF - 3.5 MB) | Clinical pharmacology (PDF - 1.2MB) | None | PREA |
| Dapsone - Aczone | Allergan, Inc. | Medical (PDF - 3.5 MB) | Clinical pharmacology (PDF - 2.6 MB) | Statistical (PDF -1.3 MB) | PREA |
| Dapsone - Aczone | Dapsone - Aczone | Medical (PDF - 3.5 MB) | Clinical pharmacology (PDF - 2.6 MB) | None | PREA |
| Daptomycin - Cubicin | Cubist Pharmaceuticals, LLC c/o Merck Sharp & Dohme Corp. | Medical (PDF - 505 KB) | Clinical pharmacology (PDF - 1.8 MB) |
Statistical (PDF -1.9 KB) |
PREA |
| Daptomycin - Cubicin | Cubist Pharmaceuticals, LLC c/o Merck Sharp & Dohme Corp. | Medical (PDF - 389 KB) |
Clinical pharmacology (PDF - 991 KB)
Clinical pharmacology Addendum (PDF - 80 KB) |
Statistical (PDF - 374 KB) |
PREA |
| Darbepoetin alfa - Aranesp | Amgen Inc. | Medical (PDF -1.6MB) | None | Statistical (PDF -280KB) | BPCA |
| Darunavir and Cobicistat - Prezcobix | Janssen Products, LP | Medical (PDF - 147 KB) | Clinical pharmacology (PDF - 20 KB) | None | PREA |
| Darunavir - Prezista | Janssen Products, L.P. | Medical (PDF -1MB) | Clinical pharmacology (PDF -1MB) | None | PREA |
| Darunavir - Prezista | Janssen Products, L.P. | None | Clinical pharmacology (PDF -352KB) | None | PREA |
| Darunavir, Cobicistat, Emtricitabine, and Tenofovir Alafenamide - Symtuza | Janssen Products, L.P. | Multi-disciplinary review (PDF - 8 MB) | None | None | PREA |
|
Dasatinib - Sprycel
|
Bristol-Myers Squibb Company |
CDTL Review (PDF - 1 MB) Medical (PDF- 8 MB) |
Clinical pharmacology (PDF - 531 KB) |
Statistical (PDF - 19 KB) | BPCA |
| Dasiglucagon - Zegalogue | Zealand Pharma A/S | Medical (PDF - 5MB) |
Clinical pharmacology (PDF - 33KB) Clinical pharmacology Addendum (PDF - 38KB) |
Statistical (PDF - 2MB) | PREA |
| Daunorubicin and cytarabine (liposome injection) - Vyxeos | Jazz Pharmaceuticals | Multidisciplinary (PDF - 5 MB) | None | None | PREA |
| Decitabine - Dacogen | Eisai Inc. | Medical (PDF -2MB) | Clinical pharmacology (PDF -1MB) | None | BPCA |
| Deferasirox - Jadenu | Novartis Pharmaceuticals Corporation | Medical (PDF - 9 MB) | Clinical pharmacology (PDF - 1.5MB) | Statistical (PDF - 2MB) | PREA |
| Desoximetasone - Topicort | Taro Pharmaceuticals U.S.A., Inc. | Medical (PDF - 221 KB) | Clinical pharmacology (PDF - 302 KB) | None | PREA |
| Desvenlafaxine - Pristiq | Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. |
Medical (PDF - 103 KB) Medical (PDF - 622 KB) |
Clinical pharmacology (PDF - 1.5 MB) | Statistical (PDF - 1.5 MB) | PREA |
|
Deutetrabenazine - Austedo |
Teva Branded Pharmaceutical Products R&D, Inc. | Medical (PDF - 622 KB) | None | None | PREA |
| Dexlansoprazole - Dexilant | Takeda Pharmaceuticals USA Inc. | CDTL Review (PDF-661 KB) Medical (PDF-5 MB) |
Clinical pharmacology (PDF-1MB) | Statistical (PDF-50KB) | PREA |
| Dexmedtomidine hydrochloride - Precedex | Hospira | Medical (PDF -5MB) | Clinical pharmacology (PDF -3.8MB) | Statistical (PDF -1MB) | BPCA |
|
Diclofenac epolamine topical system 1.3% - Flector |
IBSA Institut Biochimique SA |
Medical (PDF - 1 MB) |
None | None | PREA |
| Diclofenac potassium - Zipsor |
Assertio Therapeutics, Inc. | Medical (PDF - 2 MB) | Clinical pharmacology (PDF - 453 KB) | None | PREA |
| Difluprednate ophthalmic emulsion - Durezol | Alcon Pharmaceuticals Ltd. c/o Alcon Research Ltd | Medical (PDF -748KB) | Clinical pharmacology (PDF -40KB) | Statistical (PDF -479KB) | BPCA |
| Dolutegravir - Tivicay | ViiV Healthcare | Medical (PDF -7.8MB) | Clinical pharmacology (PDF -10.8MB) | Statistical (PDF -4MB) | PREA |
| Dolutegravir - Tivicay | ViiV Healthcare | Medical (PDF -1.6MB) CDTL Review (PDF -932KB) |
Clinical pharmacology (PDF -2.2MB) | None | PREA |
| Dolutegravir - Tivicay PD | ViiV Healthcare | Medical (PDF -241KB) | Clinical pharmacology (PDF -89KB) | None | PREA |
| Doxycycline hyclate delayed-release - Doryx | Mayne Pharma International, Pty, Ltd. c/o Warner Chilcott US, LLC | Medical (PDF -241KB) | Clinical pharmacology (PDF -89KB) | Statistical (PDF -131KB) | PREA |
| Drospirenone and estetrol tablets - Nextstellis |
Mayne Pharma LLC | Medical (PDF - 3 MB) | None | None | PREA |
| Drospirenon - Slynd | Exeltis USA, Inc | Medical (PDF - 1 MB) | None | None | PREA |
| Duloxetine - Cymbalta | Eli Lilly and Company, Inc. | Medical (PDF -2.2 MB) | Clinical pharmacology (PDF -197KB) | Statistical (PDF -2.8MB) | PREA |
| Duloxetine - Cymbalta | Eli Lily and Company, Inc. | Medical (PDF -2.2 MB) | None | None | PREA |
| Duloxetine delayed-release capsules - Drizalma Sprinkle |
Sun Pharma Global FZE | Medical (PDF - 2 MB) | None | None | PREA |
| Duloxetine hydrochloride - Cymbalta | Eli Lilly and Company | Medical (PDF - 8MB) | Clinical pharmacology (PDF -959KB) | Statistical (PDF -665KB) | BPCA |
| Dupilumab - Dupixent | Regeneron Pharmaceuticals, Inc. | Medical (PDF - 8MB) | None | None | PREA |
| Dupilumab - Dupixent | Regeneron Pharmaceuticals, Inc. | Medical (PDF - 8MB) | None | None | PREA |
| Econazole nitrate - Ecoza | AmDerma Pharmaceuticals, LLC | Medical (PDF -2 MB) | Clinical pharmacology (PDF -2.5MB) | Statistical (PDF -422KB) | PREA |
| Efavirenz, lamivudine, tenofovir - Symfi Lo | Mylan Pharmaceuticals, Inc. | Medical (PDF - 129 KB) | Clinical pharmacology (PDF - 1 MB) | None | PREA |
| Efavirenz, lamivudine, tenofovir Disoproxil Fumarate - Symfi | Mylan Pharmaceuticals, Inc. | Medical (541 - KB) | None | None | PREA |
| Efavirenz, Lamivudine and Tenofovir disoproxil fumarate | Aurobindo Pharma Limited, India | DD Review (PDF - 65 KB) | Clinical pharmacology (PDF - 788 KB) | None | PREA |
|
Efavirenz, lamivudine, tenofovir disoproxil fumarate
|
Macleods Pharmaceuticals Limited, India | Medical (PDF - 1.9MB) | Clinical pharmacology (PDF - 788 KB) | None | PREA |
| Efavirenz - Sustiva | Bristol-Myers Squibb Company | Medical (PDF -1.9MB) | Clinical pharmacology (PDF -9.3MB) | None | BPCA |
| Efinaconazole - Jublia |
Bausch Health Americas, Inc. |
Medical (PDF - 538 KB) | None | None | PREA |
|
Elbasvir and grazoprevir - Zepatier NEW |
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. | Medical (PDF - 1 MB) | Clinical pharmacology (PDF - 1 MB) | ||
| Eltrombopag - Promacta | Novartis Pharmaceuticals Corporation | Medical (PDF -3.5MB) | Clinical pharmacology (PDF -1.2MB) | Statistical (PDF -1MB) | BPCA |
| Eltrombopag - Promacta | Novartis Pharmaceuticals Corporation | Medical (PDF - 58 KB) | None | None | PREA |
| Elvitegravir, Cobicistat, Emtricitabine, and Tenofovir alafenamide - Genvoya | Gilead Sciences, Inc. | Medical (PDF -13.4MB) | Clinical pharmacology (PDF -24.2MB) | Statistical (PDF -2.2MB) | PREA |
| Elvitegravir, Cobicistat, Emtricitabine, and Tenofovir alafenamide - Genvoya | Gilead Sciences, Inc. | Medical (PDF - 642 KB) | Clinical pharmacology (PDF - 242 KB) | None | PREA |
| Elvitegravir, Cobicistat, Emtricitabine/Tenofovir Disoproxil Fumarate - Stribild | Gilead Sciences, Inc. | CTDL Review (PDF -359KB) | Clinical pharmacology (PDF - 462KB) | None | PREA |
| Emtricitabine, Rilpivirine, and Tenofovir alafenamide - Odefsey | Gilead Sciences, Inc. | Medical (PDF -310KB) CTDL Review (PDF -578KB) |
Clinical pharmacology (PDF -5MB) Clinical pharmacology addendum (PDF -297KB) |
None | PREA |
| Emtricitabine, Rilpivirine, and Tenofovir alafenamide - Descovy | Gilead Sciences, Inc. | Medical (PDF -1.27MB) Addendum (PDF -572KB) |
Clinical pharmacology (PDF -7.6MB) | Statistical (PDF -1.9MB) | PREA |
| Emtricitabine, Rilpivirine, and Tenofovir alafenamide - Descovy | Gilead Sciences, Inc. | Medical (PDF -1.27MB) | Clinical pharmacology (PDF -7.6MB) | Statistical (PDF -1.9MB) | PREA |
| Emtricitabine and tenofovir alafenamide - Descovy | Gilead Sciences, Inc. | Medical (PDF - 642 KB) | Clinical pharmacology (PDF -145KB) | None | PREA |
| Emtricitabine and tenofovir alafenamide - Descovy NEW | Gilead Sciences, Inc. | CDTL Review (PDF - 2 MB) | None | None | PREA |
| Emtricitabine, Rilpivirine, and Tenofovir isoproxil fumarate - Complera | Gilead Sciences, Inc. | Medical (PDF -1MB) | Clinical pharmacology (PDF -145KB) | None | PREA |
| Emtricitabine and Tenofovir disoproxil fumarate - Truvada | Gilead Sciences, Inc. | Medical (PDF -501KB) | Clinical pharmacology (PDF -189KB) | None | PREA |
| Entecavir - Baraclude | Bristol-Myers Squibb Company | Medical (PDF -3.4MB) | Clinical pharmacology (PDF -3MB) | Statistical (PDF -660KB) | BPCA |
| Entrectinib - Rozlytrek | Genentech | Medical (PDF - 23 MB) | None | None | BPCA |
| Erlotinib - Tarceva | OSI Pharmaceuticals, LLC | Medical (PDF -6.2MB) | Clinical pharmacology (PDF -2.2MB) | None | BPCA |
| Epinephrine - Auvi-Q | Kaleo, Inc. | Medical (PDF - 1.8 MB) | None | None | PREA |
| Escitalopram oxalate - Lexapro | Forest Laboratories, Inc. | Medical (PDF -218KB) | None | None | BPCA |
| Eslicarbazepine acetate - Aptiom | Sunovion Pharmaceutical Inc. | CDTL Review (PDF - 593 KB) Medical (PDF - 5 MB) |
Clinical pharmacology (PDF - 2.9 KB) | None | PREA |
| Eszopiclone - Lunesta | Sunovion Pharmaceuticals, Inc. | Medical (PDF -1MB) | Clinical pharmacology (PDF -883KB) | None | BPCA |
| Etanercept - Enbrel | Immunex Corporation, a wholly-owned subsidiary of Amgen Inc. |
Medical (PDF - 4.8 MB) DD Review (PDF - 568 KB) CDTL Review PDF - 504 KB) |
Clinical pharmacology (PDF - 702 KB) | Statistical (PDF - 444 KB) | PREA |
| Etanercept-szzs - Erelzi | Sandoz Inc. | Medical (PDF - 1.7 MB) | Clinical pharmacology (PDF - 4.7 MB) | Statistical (PDF - 432 KB) | PREA |
| Etanercept-szzs - Erelzi |
Sandoz Inc. |
CDTL Review PDF - 504 KB) |
None | None | PREA |
| Etravirine - Intelence | Janssen Products, LP | Medical (PDF -1.4MB) | Clinical pharmacology (PDF -1.7MB) | None | PREA |
| Etravirine - Intelence | Janssen Products, LP | Medical (PDF -1 MB) | Clinical pharmacology (PDF - 896 KB) | None | BPCA |
| Everolimus tablets for oral suspension - Afinitor Disperz | Novartis Pharmaceuticals Corporation | Medical (PDF -10MB) | Clinical pharmacology (PDF -2MB) | None | BPCA |
| Evolocumab - Repatha | Amgen, Inc. | Medical (PDF - 5 MB) | Clinical pharmacology (PDF - 1 MB) | Statistical (PDF - 1 MB) | PREA |
| Exenatide - Bydureon | AstraZeneca Pharmaceuticals AB C/O AstraZeneca Pharmaceuticals LP | Medical (PDF - 3 MB) | Clinical pharmacology (PDF - 2 MB) | Statistical (PDF - 1 MB) | BPCA |
| Ferric oxyhydroxide - Velphoro | Vifor Fresenius Medical Care Renal Pharma France | Medical (PDF - 1 MB) | None | None | BPCA |
| Fesoterodine fumarate - Toviaz | Pfizer, Inc. |
Medical (PDF - 4 MB) | Clinical pharmacology (PDF - 6 MB) | Statistical (PDF - 300 KB) | PREA |
|
Fidaxomicin - Dificid |
Cubist Pharmaceuticals LLC | Medical (PDF -3.8MB) | None | None | BPCA |
| Filgrastim-sndz - Zarxio | Sandoz, Inc. | Medical (PDF -3.8MB) DD Review (PDF -86KB) TL Review (PDF -422KB) |
Clinical pharmacology (PDF -2.75MB) Addendum (PDF - 1.1MB) |
Statistical (PDF -6742KB) | PREA |
| Filgrastim-aafi - Nivestym | Hospira, Inc. |
CDTL Review (PDF - 746 KB) Medical (PDF - 245 KB) |
Clinical pharmacology (PDF - 661 KB) | Statistical (PDF - 377 KB) | PREA |
| Finafloxacin otic suspension - Xtoro | Alcon Research, Ltd. | Medical (PDF -6.8MB) | Clinical pharmacology (PDF -2MB) | Statistical (PDF -3.2MB) | BPCA |
| Fingolimod - Gilenya | Novartis Pharmaceuticals Corporation |
CDTL Review (PDF - 2 MB) Medical (PDF - 3.8 MB) |
Clinical pharmacology (PDF -2MB) | Statistical (PDF -3.2MB) | PREA |
| Fluticasone furoate inhalation powder - Arnuity Ellipta | GlaxoSmithKline | Medical (PDF -8.6MB) | Clinical pharmacology (PDF -5.7MB) | Statistical (PDF -1.9) | PREA |
| Fluticasone furoate - Arnuity Ellipta | GlaxoSmithKline | Medical (PDF - 956 KB) | Clinical pharmacology (PDF - 2 MB) | Statistical (PDF - 507 KB) | PREA |
| Fluticasone Furoate/Umeclidinium/Vilanterol - Trelegy Ellipta | GlaxoSmithKline Intellectual Property Development Ltd. England | Medical (PDF -3MB) | None | None | PREA |
| Fluticasone propionate Lotion - Cutivate | Fougera Pharmaceuticals Inc. | Medical (PDF -3MB) | Clinical pharmacology (PDF -1MB) | Statistical (PDF -317MB) | PREA |
| Fluticasone propionate Lotion - Cutivate | Fougera Pharmaceuticals Inc. | Medical (PDF -1.2MB) | Clinical pharmacology (PDF -1.4MB) | None | PREA |
| Fluticasone propionate/salmeterol xinafoate - Advair HFA | GlaxoSmithKline | Medical (PDF -1 MB) | Clinical pharmacology (PDF -267KB) | Statistical (PDF -52 KB) | PREA |
| Fluticasone propionate - ArmonAir RespiClick | Teva Pharmaceutical Industries Ltd. | Medical (PDF -10 MB) | Clinical pharmacology (PDF - 4.3MB) | Statistical (PDF -1.2 KB) | PREA |
|
Fluticasone propionate - ArmonAir RespiClick |
Teva Pharmaceutical Industries Ltd. c/o: Teva Branded Pharmaceutical Products R&D Inc. | Medical (PDF - 6 MB) | None | None | PREA |
| Fluticasone propionate/salmeterol - AirDuo | Teva Pharmaceutical Industries Ltd. | Medical (PDF -10 MB) | Clinical pharmacology (PDF - 4.3 MB) | Statistical (PDF -1.2 KB) | PREA |
|
Formoterol fumarate and mometasone furoate - Dulera |
Merck Sharp & Dohme Corp. | Medical (PDF -10 MB) | |||
| Fosaprepitant - Emend | Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. | Medical (PDF - 2 MB) | Clinical pharmacology (PDF - 7 MB) | Statistical (PDF - 662 KB) | BPCA |
| Fosphenytoin sodium - Cerebyx | Parke-Davis, a Division of Pfizer, Inc. | CDTL Review (PDF - 390 KB) Medical (PDF - 1.5 MB) |
Clinical pharmacology (PDF - 5 MB) | None | PREA |
| Gadobutrol - Gadavist | Bayer HealthCare Pharmaceuticals, Inc. | Medical (PDF -958KB) | Clinical pharmacology (PDF -2.2MB) | Statistical (PDF -422 KB) | PREA |
| Gadobutrol - Gadavist | Bayer Healthcare Pharmaceuticals, Inc. | Medical (PDF -7MB) | None | Statistical (PDF -782 KB) | PREA |
| Gadoterate meglumine - Dotarem | Guerbet LLC | Medical (PDF -3MB) | Clinical pharmacology (PDF -768KB) | Statistical (PDF -1.2 MB) | PREA |
| Gadoterate meglumine - Dotarem | Guerbet LLC | Medical (PDF 1.3 MB) | Clinical pharmacology (PDF - 1.5 MB) | Statistical (PDF - 398 KB) | PREA |
| Gadoteridol - ProHance | Bracco Diagnostics, Inc | Medical (PDF - 3 MB) | None | None | PREA |
| Gadoxetate disodium - Eovist | Bayer HealthCare Pharmaceuticals, Inc. | Medical (PDF -1.2MB) | Clinical pharmacology (PDF -1.5MB) | None | PREA |
| Gatifloxacin ophthalmic solution - Zymar | Allergan, Inc. | Medical (PDF - 78 KB) | None | None | PREA |
| Gatifloxacin - Zymar | Allergan, Inc. | DDTL (PDF - 428 KB) | None | None | Both |
| Glecaprevir and Pibrentasvir - Mavyret | AbbVie Inc. |
CTDL (PDF - 2 MB) CTDL Addendum (PDF - 187 KB) |
Clinical pharmacology (PDF - 409 KB) | Statistical (PDF - 439 KB) | PREA |
| Glecaprevir and Pibrentasvir - Mavyret | AbbVie Inc. | Medical (PDF - 78 KB) | None | None | PREA |
| Glecaprevir and pibrentasvir - Mavyret | AbbVie, Inc. | Medical (PDF - 2 MB) | Clinical pharmacology (PDF - 3 MB) | None | BPCA |
| Glucagon - Gvoke | Xeris Pharmaceuticals, Inc. | Medical (PDF - 3 MB) CTDL Review (PDF - 3 MB |
Clinical pharmacology (PDF - 2 MB) | Statistical (PDF - 2 MB) | PREA |
| Glucagon - Baqsimi | Eli Lilly and Company |
Medical (PDF - 3 MB) CTDL Review (PDF - 3 MB |
Clinical pharmacology (PDF - 2 MB) | Statistical (PDF - 2 MB) | PREA |
| Glycopyrronium - Qbrexza | Dermira, Inc. | Medical (PDF - 6 MB) | None | None |
PREA
|
| Golimumab - Simponi | Janssen Biotech, Inc. |
Medical (PDF - 3.1 MB) |
Clinical pharmacology (PDF - 307 KB) | Statistical (PDF - 1.1 MB) | PREA |
| Golimumab - Simponi Aria | Janssen Biotech, Inc. | Medical (PDF - 4 MB) | None | None | PREA |
| Guanfacine - Intuniv | Shire | Medical (PDF - 2 MB) CTDL Review (PDF -134 KB) |
Clinical pharmacology (PDF - 330 KB) | Statistical (PDF - 544 KB) | Both |
| Guanfacine - Intuniv | Shire | Medical (PDF -3MB) | Clinical pharmacology (PDF - 667KB) | Statistical (PDF -3MB) | PREA |
| Halobetasol - Propionate Ultravate | Sun Pharmaceutical Industries, Inc. | Medical (PDF - 150 KB) | Clinical pharmacology (PDF - 303 KB) | None | PREA |
|
Halobetasol Propionate - Lexette |
Mayne Pharma LLC |
Medical (PDF - 249 KB) | Clinical pharmacology (PDF - 752 KB) | None | BPCA |
| Ibrexafungerp - Brexafemme | SCYNEXIS, Inc. | Medical (PDF - 10 MB) | None | None | PREA |
| Ibuprofen - Caldolor | Cumberland Pharmaceuticals, Inc. | DD Summary Review (PDF -669KB) Medical (PDF -3MB) |
Clinical pharmacology (PDF -3.7MB) | Statistical (PDF -378KB) | PREA |
| IncobotulinumtoxinA - Xeomin | Merz Pharmaceuticals GmbH | Medical (PDF - 2 MB) | None | Statistical (PDF - 1 MB) | PREA |
|
Indocyanine green for Injection - Spy Agent Green
|
Novadaq Technologies ULC | Medical (PDF - 4 MB) | None | None | PREA |
|
Indocyanine green for Injection - Spy Agent Green
|
Novadaq Technologies ULC | Medical (PDF - 4 MB) | None | None | PREA |
| Infliximab-axxq - Avsola | Amgen, Inc. | Medical (PDF - 4 MB) | None | None | PREA |
| Infliximab-dyyb - Inflectra | Celltrion, Inc. | Medical (PDF -5.3MB) Addendum (PDF - 1MB) |
None | Statistical (PDF -2MB) | PREA |
| Infliximab-abda - Renflexis | Samsung Bioepsis Co., Ltd |
CDTL Review (PDF - 1 MB) Medical (PDF - 3.5 MB) Medical 2(PDF - 267 KB) Medical 3 (PDF - 93 KB) |
Clinical pharmacology (PDF - 7.7 MB) |
Statistical (PDF - 959 KB) Statistical 2 (PDF - 602 KB) |
PREA |
| Insulin aspart injection - Fiasp | Novo Nordisk Inc. |
CDTL Review (PDF - 1 MB) Medical (PDF - 3.5 MB) |
Clinical pharmacology (PDF - 4MB) | Statistical (PDF - 905KB) | PREA |
| Insulin Degludec - Tresiba | Novo Nordisk Inc. | CDTL Review (PDF - 7MB) Medical (PDF - 7 MB) |
Clinical pharmacology (PDF - 4MB) | Statistical (PDF - 905KB) | PREA |
| Insulin Degludec / Insulin Aspart) - Ryzodeg | Novo Nordisk Inc. | Medical (PDF - 7 MB) | Clinical pharmacology (PDF - 4 MB) | Statistical (PDF - 905 KB) | PREA |
|
Insulin glargine-yfgn - Semglee |
Mylan Pharmaceuticals Inc. | Medical (PDF - 8 MB) | None | None | PREA |
| Insulin glargine-aglr - Rezvoglar NEW | Eli Lilly and Company | Medical (PDF - 2 MB) | None | None | PREA |
| Iodixanol - Visipaque |
GE HealthCare Inc. |
CDTL Review (PDF - 2.4 MB) Medical (PDF - 1.9 MB) |
Clinical pharmacology (PDF - 988 KB) | Statistical (PDF - 1.8 MB) | PREA |
| Iohexol - Oraltag | Interpharma Praha, a.s. | Medical (PDF -91 KB) | Clinical pharmacology (PDF - 294 KB) | Statistical (PDF - 98 KB) | PREA |
| Ipilimumab - Yervoy | Bristol-Myers Squibb Company | Medical (PDF 5.5 MB) | Clinical pharmacology (PDF - 1.6 MB) | None | PREA |
| Iron Sucrose Injection, USP - Venofer | Luitpold Pharmaceuticals, Inc. | Medical (PDF -2 MB) | Clinical pharmacology (PDF - 114 KB) | Statistical (PDF - 576 KB) | PREA |
| Ivabradine - Corlanor | Amgen Inc. |
CDTL (PDF - 3 MB) Medical (PDF - 4 MB) |
Clinical pharmacology (PDF - 4 MB) | Statistical (PDF - 51 KB) | BPCA |
| Ixekizumab - Taltz | Eli Lilly and Company | Medical (PDF - 2 MB) | None | None | PREA |
| Kit for the Preparation of Technetium Tc 99m Pentetate Injection - Draximage | Jubilant DraxImage, Inc |
Medical (PDF - 2 MB) | None | Statistical (PDF - 376 KB) | PREA |
| Lacosamide - Vimpat | UCB, Inc. |
CDTL Review (PDF - 371 KB) Medical (PDF - 915 KB) |
Clinical pharmacology (PDF - 2 MB) | None |
PREA |
| Lacosamide - Vimpat | UCB, Inc. |
Medical (PDF - 541 KB) Medical (PDF - 631 KB) |
Clinical pharmacology (PDF - 1 MB) | Statistical (PDF - 2 MB) | PREA |
| Lacosamide - Vimpat | UCB, Inc. | Medical (PDF - 700 KB) | Clinical pharmacology (PDF - 800 KB) | None | PREA |
| Lactic acid citric acid and K bitartrate - Phexxi | Evofem, Inc. | Medical (PDF - 1 MB) | Clinical pharmacology (PDF - 1 KB) | Statistical (PDF - 3 76706 KB) | PREA |
| Lamivudine - Epivir | ViiV Healthcare Company | Medical (PDF -4.2 MB) | Clinical pharmacology (PDF - 3 MB) | PREA | |
| Lamivudine and Raltegravir - Dutrebis | Merck Sharp & Dohme Corp. | Medical (PDF -1 MB) | Clinical pharmacology (PDF - 6.4 MB) | None | PREA |
| Lamivudine and tenofovir - Cimduo | Mylan Pharmaceuticals India | Medical (PDF - 73 KMB) | Clinical pharmacology (PDF - 1 MB) | None | PREA |
|
Lamivudine and tenofovir disoproxil fumarate - Temixys
|
Celltrion, Inc. |
Medical (PDF - 20 KB) |
Clinical pharmacology (PDF - 1 MB) |
None | PREA |
| Lamotrigine - Lamictal | GlaxoSmithKline LLC | Medical (PDF -18 MB) | Clinical pharmacology (PDF - 793 KB) | Statistical (PDF - 1.8 MB) | PREA |
| Ledipasvir-sofosbuvir - Harvoni | Gilead Sciences, Inc. | Medical and CDTL (PDF - 1.5 MB) | Clinical pharmacology (PDF - 539 KB) | Statistical (PDF - 205 KB) | PREA |
| Ledipasvir-sofosbuvir - Harvoni | Gilead Sciences, Inc. | Medical (PDF - 426 KB) | None | None | PREA |
| Ledipasvir-sofosbuvir - Harvoni | Gilead Sciences, Inc. | Medical (PDF - 280 KB) | None | None | BPCA |
| Leuprolide acetate - Fensolvi | Tolmar, Inc. | Medical (PDF - 280 KB) | Clinical pharmacology (PDF - 3.9 MB | Statistical (PDF - 2 MB) | PREA |
| Levalbuterol hydrochloride - Xopenex | Oak Pharmaceuticals | Medical (PDF -8.3 MB) | Clinical pharmacology (PDF - 3.9 MB) | Statistical (PDF - 2 MB) | PREA |
| Levalbuterol tartrate - Xopenex HFA | Sunovion Pharmaceuticals Inc. | Medical (PDF -3.9 MB) | Clinical pharmacology (PDF - 1.2 MB) | Statistical (PDF 1.3 MB) | PREA |
| Levamlodipine - Conjupri | CSPC Ouyi Pharmaceutical Co., Ltd. | Medical (PDF - 2 MB) | Clinical pharmacology (PDF - 569 KB) | None | PREA |
| Levetiracetam - Keppra Extended Release Tablets | UCB, Inc. | DD Summary Review (PDF - 202KB) CDTL Review (PDF - 371 KB) Medical (PDF - 327KB) |
Clinical pharmacology (PDF - 1.2 MB) | None | PREA |
| Levonorgestrel - Liletta | Medicines360 | Medical (PDF - 8.8 MB) | Clinical pharmacology (PDF - 1M B) Clinical pharmacology (PDF - 2.4 MB) |
Statistical (PDF - 1.5 MB) | PREA |
| Levonorgestrel/ethinyl estradiol tablets | Exeltis |
CDTL (PDF - 8.8 MB) Medical (PDF - 8.8 MB) Medical (PDF - 8.8 MB) |
Clinical pharmacology (PDF - 1M B) Clinical pharmacology (PDF - 2.4 MB) |
Statistical (PDF - 1.5 MB) | PREA |
| Levonorgestrel/ethinyl estradiol and ethinyl estradiol - Quartette | Teva Branded Pharmaceutical Products R&D, Inc. | Medical (PDF -6MB) | Clinical pharmacology (PDF - 4 MB) Clinical pharmacology addendum (PDF - 89KB) |
Statistical (PDF - 1MB) | PREA |
| Levonorgestrel-releasing intrauterine system - Skyla | Bayer HealthCare Pharmaceuticals, Inc. | Medical (PDF - 8MB) | Clinical pharmacology (PDF - 4MB) | Statistical (PDF - 424 KB) | PREA |
|
Levonorgestrel releasing intrauterine system - Liletta |
Medicines360 |
CDTL Review (PDF - 179KB) Medical (PDF - 2 MB) |
Clinical pharmacology (PDF - 1 MB) | Statistical (PDF - 168 KB) | PREA |
|
Levonorgestrel - Mirena |
Bayer HealthCare Pharmaceuticals, Inc. | Medical (PDF - 2 MB) | None | None | PREA |
| Levothyroxine sodium oral solution - Tirosint-SOL | Cromsource, Inc. |
CDTL Review (PDF - 461 KB) Medical (PDF - 2.8 MB) |
Clinical pharmacology (PDF - 1.8 MB) | None | PREA |
|
Liraglutide - Saxenda |
Novo Nordisk, Inc. | Medical (PDF - 5 MB) | Clinical pharmacology (PDF - 5 MB) | Statistical (PDF - 2 MB) | PREA |
| Liraglutide - Victoza | Novo Nordisk Inc. | Medical (PDF - 8 MB) | Clinical pharmacology (PDF - 864 KB) | Statistical (PDF - 450 KB) | BPCA |
| Lisdexamfetamine dimesylate - Vyvanse | Shire Development, LLC | Medical (PDF - 218 KB) | Clinical pharmacology (PDF - 1 MB) | None | PREA |
| Lisdexamfetamine mesylate - Vyvanse | Shire | Medical (PDF - 2.4 MB) | None | Statistical (PDF - 1 MB) | PREA |
|
Lisdexamfetamine dimesylate - Vyvanse
|
Takeda Pharmaceuticals U.S.A., Inc. | Medical (PDF - 804 KB) | None | None | BPCA |
| Liisenatide - Adlyxin |
Sanofi-aventis U.S. LLC | Medical (PDF - 182 MB) | Clinical pharmacology (PDF - 1 MB) | None | PREA |
| Pitavastatin - Livalo | Kowa Pharmaceuticals America, Inc. |
CDTL Review (PDF - 526 KB) Medical (PDF - 2 MB) |
Clinical pharmacology (PDF - 3 MB) | Statistical (PDF - 240 KB) | PREA |
| Loteprednol - Lotemax | Bausch & Lonb Inc. |
Medical (PDF - 318 KB) Medical (PDF - 218 KB) |
None | Statistical (PDF - 3 MB) | PREA |
| Luliconazole - LuzuTM | Medicis Pharmaceutical Corporation, a division of Valeant Pharmaceuticals NA LLC |
CDTL (PDF - 358 KB) CDTL (PDF - 372 KB) Medical (PDF - 306 KB) Medical (PDF - 616 KB) |
Clinical pharmacology (PDF -1 MB) Clinical pharmacology (PDF - 423 KB) |
Statistical (PDF - 207 KB) | PREA |
| Lopinavir / Ritonavir - Kaletra | AbbVie Inc. | Medical (PDF - 5.8 MB) | Clinical pharmacology (PDF -2.3 MB) | Statistical (PDF - 1.9 MB) | PREA |
| Lubiprostone - Amitizia | Sucampo Pharmaceuticals Inc. | Medical (PDF - 11 MB) | Clinical pharmacology (PDF - 1 MB) | Statistical (PDF - 1 MB) | PREA |
| Lurasidone hydrochloride - Latuda | Sunovion Pharmaceuticals, Inc. |
Medical (PDF - 6 MB) Medical (PDF - 7 MB) |
Clinical pharmacology (PDF - 3 MB) |
Statistical (PDF - 369 KB) Statistical (PDF - 255 KB) |
PREA |
| Lurasidone hydrochloride - Latuda | Sunovion Pharmaceuticals, Inc. |
CDTL (PDF - 6 MB) Medical (PDF - 6 MB) |
Clinical pharmacology (PDF - 2 MB) | Statistical (PDF - 368 KB) | PREA |
| Lurasidone hydrochloride - Latuda | Sunovion Pharmaceuticals, Inc. | Medical (PDF - 1.0 MB) | None | None | PREA |
| Maraviroc - Selzentry | Viiv Healthcare | Medical (PDF - 1.0 MB) | Clinical pharmacology (PDF - 2.8 MB) | None | PREA |
| Maraviroc - Selzentry | Viiv Healthcare | Medical (PDF - 1 MB) | Clinical pharmacology (PDF - 3 MB) | None | PREA |
| Memantine hydrochloride - Namenda XR | Forest Research Institute, Inc. (subsidiary of Forest Laboratories Inc.) | Medical (PDF - 2.1 MB) | Clinical pharmacology (PDF - 956 KB) | Statistical (PDF - 1.1 MB) | BPCA |
| Mepolizumab - Nucala | GlaxoSmithKline LLC | Medical (PDF - 8 MB) | Clinical pharmacology (PDF - 6 MB) Clinical pharmacology addendum (PDF -425KB) |
Statistical (PDF - 1.4 MB) | PREA |
| Mepolizumab - Nucala | GlaxoSmithKline LLC | Medical(PDF - 8 MB) | None | None | PREA |
| Mepolizumab - Nucala | GlaxoSmithKline LLC | Medical (PDF - 8 MB) | None | None | PREA |
| Mirabegron - Myrbetriq | Astellas Pharma Global Development, Inc. | Medical (PDF - 13MB) |
Clinical pharmacology (PDF - 2.8MB) |
Statistical (PDF - 168KB) | BPCA |
| Mesalamine - Asacol HD | Warner Chilcott | Medical (PDF - 6MB) | Clinical pharmacology (PDF - 3.2 MB) Clinical pharmacology (PDF - 518 KB) |
Statistical (PDF -499KB) | PREA |
| Mesalamine - Canasa | Forest Laboratories | Medical (PDF - 6 MB) | Clinical pharmacology (PDF - 251KB) | Statistical (PDF - 344 KB) | PREA |
| Mesalamine - Delzicol | Warner Chilcott LLC | Medical (PDF - 707 KB) Medical Addendum(PDF - 495 KB) |
Clinical pharmacology (PDF -116KB) | None | PREA |
| Mesalamine - Delzicol | Warner Chilcott (US), LLC | Medical (PDF - 4.7 MB) | Clinical pharmacology (PDF - 729 KB) | Statistical (PDF - 1.1KB) | PREA |
| Mesalamine - Lialda | Shire Development, LLC | Medical (PDF - 6 MB) | |||
|
Metformin hydrochloride for extended-release oral suspension - Riomet ER |
Pharmaceutical Industries Limited | CTDL Review (PDF - 917 KB) | Clinical pharmacology (PDF - 818 KB) | None | PREA |
| 10% Methyl salicylate, 3% L-menthol - Salonpas Pain Relief | Hisamitsu Pharmaceutical Co., Inc. | Medical (PDF - 998 KB) Medical (PDF - 3 MB) |
Clinical pharmacology (PDF - 2.6 MB) | Statistical (PDF - 1.4 MB) | PREA |
|
Methylphenidate hydrochloride extended-release - Aptensio XR |
Rhodes Pharmaceuticals L.P. | Medical (PDF - 2.3 MB) | Clinical pharmacology (PDF - 3.6M B) | Statistical (PDF - 1.1 MB) Statistical (PDF - 629 KB) |
PREA |
| Methylphenidate hydrochloride - Quillivant XR | NextWave Pharmaceuticals, Inc. | Medical (PDF - 26 KB) | Clinical pharmacology (PDF - 588 KB) | Statistical (PDF - 380 KB) | PREA |
| Methylphenidate hydrochloride extended release chewable tablets - QuilliChew ER | Pfizer Inc. | CTDL Review (PDF -1.3MB) Medical (PDF - 4.8 MB) |
Clinical pharmacology (PDF -2.9MB) | Statistical (PDF -498KB) | PREA |
|
Methylphenidate HCL extended-release capsules - Adhansia XR |
Purdue Pharma |
Medical (PDF - 2 MB) Medical (PDF - 4.8 MB) |
Clinical pharmacology (PDF - 2 MB) |
Statistical (PDF - 1 MB) Statistical (PDF - 2 MB) |
PREA |
| Methylphenidate hydrochloride - Aptensio XR | Rhodes Pharmaceuticals L.P. | CTDL Review (PDF - 592 KB) Medical (PDF - 3 MB) |
Clinical pharmacology (PDF - 2 MB) |
Statistical (PDF - 1 MB) Statistical (PDF - 139 KB) |
BPCA |
|
Methylphenidate hydrochloride - Jornay PM
|
Ironshore Pharmaceuticals & Development, Inc. | Medical (PDF - 4.8 MB) | Clinical pharmacology (PDF - 2.1 MB) | Statistical (PDF - 921 KB) | PREA |
| Methylphenidate extended-release orally disintegrating tablets - Cotempla XR-ODT | Neos Therapeutics, Inc. |
Medical (PDF - 5.7 MB) Medical (PDF - 1.2 MB) |
Clinical pharmacology (PDF - 2.1 MB) Clinical pharmacology (PDF - 2.1 MB) |
Statistical (PDF - 921 KB) Statistical (PDF - 96 KB) |
PREA |
| Methoxy polyethylene glycol-epoetin beta - Mircera | Vifor International AG | Medical (PDF - 2.3 MB) | None |
Statistical (PDF - 239 KB) |
PREA |
| Metoprolol Succinate - KAPSPARGO SPRINKLE | Sun Sun Pharmaceutical Industries LimitedPharmaceutical Industries Limited | Medical (PDF - 799 KB) | Clinical pharmacology (PDF - 978 KB) | None | PREA |
| Metronidazole vaginal gel 1.3% - Nuvessa | Chemo Research SL | Medical (PDF - 1.2 MB) | Clinical pharmacology (PDF - 70 KB) | Statistical (PDF - 127 KB) | PREA |
| Micafungin for injection - Mycamine | Astellas Pharma US, Inc. | Medical (PDF - 1.2 MB) | None | None | BPCA |
| Micafungin sodium - Mycamine | Astellas Pharma US, Inc. | Medical (PDF - 2.2 MB) |
Clinical pharmacology (PDF - 4.4MB) |
Statistical (PDF -987KB) | BPCA |
| Minocycline - Amzeeq |
Foamix Pharmaceuticals Inc. | Medical (PDF - 2.2 MB) | None | None | PREA |
| Mirabegron extended-release tablets and mirabegron extended-release for oral suspension - Myrbetriq and Myrbetriq Granules NEW | Astellas Pharma Global Development, Inc. | Medical (PDF - 13 MB) | None | None | BPCA |
| Mixed salts of a single-entity amphetamine product - Mydayis | Shire Development, LLC. |
Medical (PDF - 6.8 MB) |
Clinical pharmacology (PDF -1.8KB) | Statistical (PDF -987KB) | PREA |
| Mixed salts of a single entity amphetamine product - Mydayis | Shire Development, LLC. | Medical (PDF - 6.8 MB) | None | None | BPCA |
| Mometasone furoate - Asmanex HFA | Merck Sharp & Dohme Corp. | Medical (PDF -2.7MB) | Clinical pharmacology (PDF -1.5MB) | Statistical (PDF -603KB) | PREA |
| Mometasone furoate - Asmanex HFA | Merck Sharp & Dohm Corp | Medical (PDF-1MB) | None | None | PREA |
| Mometasone furoate and formoterol fumarate - Dulera | Schering-Plough | Medical (PDF-1MB) | None | None | PREA |
| Morphine sulfate injection | Hospira, Inc. | CDTL (PDF - 2 MB) | None | None | PREA |
|
Moxifloxacin - Avelox |
Bayer Pharmaceuticals | Medical (PDF- 905KB) | Clinical pharmacology (PDF -1.8MB) | Statistical (PDF - 760KB) | PREA |
| Moxifloxacin ophthalmic solution - Vigamox | Alcon Pharmaceuticals, Ltd. | Medical (PDF - 434 KB) DD Summary Review (PDF- 118 KB) |
None | None | BPCA |
| Naftifine hydrochloride - Naftin | Merz Pharmaceuticals, LLC | Medical (PDF - 488 KB) | Clinical pharmacology (PDF - 1 MB) | Statistical (PDF - 188 KB) | PREA |
| Naftifine hydrochloride - Naftin Cream, 2% | Merz Pharmaceuticals, LLC | Medical (PDF - 1.2MB) | Clinical pharmacology (PDF -1.6MB) | Statistical (PDF - 822KB) | PREA |
| Naloxone hydrochloride - Narcan Nasal Spray | Adapt Pharma Operations Limited | DD Summary Review(PDF -1.2MB) CTDL Review (PDF -3MB) |
Clinical pharmacology (PDF -1.5MB) | None | PREA |
| Naproxen sodium 220 mg and Diphenhydramine hydrochloride - Aleve PM | Bayer HealthCare, LLC – Consumer Care | Medical (PDF -1MB) | Clinical pharmacology (PDF -1.7MB) | Statistical (PDF -1.3MB) | PREA |
| Naproxen and esomeprazole magnesium - Vimovo | Horizon Pharma Inc. | Medical (PDF - 3.8 MB) | Clinical pharmacology (PDF -2.3 MB) | None | PREA |
| Neostigmine methylsulfate - Bloxiverz | Eclat Pharmaceuticals, LLC | Medical (PDF -7.7MB) | Clinical pharmacology (PDF -2MB) | None | PREA |
| Nevirapine - Viramune XR | Boehringer Ingelheim Pharmaceuticals, Inc. | Medical (PDF -2MB) | Clinical pharmacology (PDF -446KB) | Statistical (PDF - 723KB) | PREA |
| Nilotinib - Tasigna | Sponsor: Novartis Pharmaceuticals Corporation | Medical (PDF - 1.2 MB) | Clinical pharmacology (PDF - 1.6 MB) | Statistical (PDF - 124 KB) | BPCA |
| Nitisinone - NITYR | Cycle Pharmaceuticals Ltd. | Medical (PDF - 358 KB) | Clinical pharmacology (PDF - 3.6 MB) | None | PREA |
| Nitisinone - NITYR | Cycle Pharmaceuticals Ltd. | Medical (PDF - 358 KB) | None | None | PREA |
| Nivolumab - Opdivo |
Bristol-Myers Squibb Company |
DD (PDF - 188 KB) Medical (PDF - 222 KB) |
Clinical pharmacology (PDF - 202 KB) Clinical pharmacology (PDF - 250 KB) |
Noen | PREA |
| Norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules - Taytulla | Warner Chilcott Company, LLC | Medical (PDF -1MB) | Clinical pharmacology (PDF -3.2MB) | Statistical (PDF - 469KB) | PREA |
| Obiltoxaximab - Anthim | Elusys Theraputics, Inc. | Medical (PDF -18MB) Addendum (PDF -249KB) |
Clinical pharmacology (PDF -12MB) Addendum (PDF -126KB) |
Statistical (PDF - 9MB) | PREA |
| Ocriplasmin- Jetrea | ThromboGenics, Inc. | Medical (PDF - 817KB) | Clinical pharmacology (PDF - 117KB) | Statistical (PDF - 760KB) | PREA |
| Olanzapine and fluoxetine hydrochloride - Symbyax | Eli Lilly and Company | Medical (PDF -1.3MB) | Clinical pharmacology (PDF -1.2MB)
Addendum (PDF - 132KB) |
Statistical (PDF - 953KB) | PREA |
| Olopatadine - Pazeo | Alcon Research LTD | Medical (PDF -2.3MB) | Clinical pharmacology (PDF -340KB) | Statistical (PDF - 4.3KB) | BPCA |
| Omalizumab - Xolair | Genentech | Medical (PDF -6MB) | Clinical pharmacology (PDF -1.3MB) | Statistical (PDF - 2MB) | PREA |
| Omalizumab - Xolair | Genentech, Inc. and Novartis Pharmaceuticals Corp. | Medical (PDF-4MB) | Clinical pharmacology (PDF -1MB) | Statistical (PDF-1 MB) | PREA |
|
Omalizumab - Xolair
|
Genentech, Inc. and Novartis Pharmaceuticals Corp. | Medical (PDF - 5MB) | None | None | PREA |
| Omeprazole magnesium - Prilosec | AstraZeneca Pharmaceuticals LP | Medical (PDF -908KB) | Clinical pharmacology (PDF -1.6MB) | None | PREA |
|
OnabotulinumtoxinA - Botox |
Allergan, Inc. |
CDTL (PDF - 403 KB) Medical (PDF - 1 MB) |
None |
Statistical (PDF - 173 KB) | PREA |
| OnabotulinumtoxinA - Botox | Allergen, Inc |
Medical (PDF - 3 MB) Medical (PDF - 1 MB) |
None | Statistical (PDF - 1 MB) | PREA |
| OnabotulinumtoxinA - Botox | Allergen, Inc | Medical (PDF - 1 MB) | None | None | PREA |
| Oxcarbazepine - Oxtellar XR | Supernus Pharmaceuticals, Inc. | Medical (PDF - 5 MB) | Clinical pharmacology (PDF - 7 MB) | Statistical (PDF - 482 KB) | PREA |
| Oxycodone hydrochloride - Oxycontin | Purdue Pharma L.P. | Medical (PDF - 17 MB) | Clinical pharmacology (PDF - 2 MB) | Statistical (PDF - 678 KB) | BPCA |
| Oxycodone hydrochloride - OxyContin | Purdue Pharma L.P. | Medical (PDF - 17 MB) | Clinical pharmacology (PDF - 16 MB) | Statistical (PDF - 551 KB) | BPCA |
| Oxymorphone - Opana | Medical (PDF - 17 MB) | Clinical pharmacology (PDF - 2 MB) | None | PREA | |
| Ozenoxacin - Xepi | Ferrer Internacional S.A. | Medical (PDF - 2 MB) | Clinical pharmacology (PDF - 1 MB) | Statistical (PDF - 524 KB) | PREA |
| Paclitaxel - Abraxane | Abraxis BioScience, L.L.C., a wholly-owned subsidiary of Celgene Corporation | Medical (PDF - 235 KB) | None | None | BPCA |
| Palifermin - Kepivance | Quintiles, Inc. | Medical (PDF - 280 KB) | Clinical pharmacology (PDF - 726 KB) | None | PREA |
| Palonosetron hydrochloride - Aloxi | Helsinn Healthcare SA | Medical (PDF -15MB) Medical (PDF -2MB) |
Clinical pharmacology (PDF -2.3MB) | Statistical (PDF - 771KB) | BPCA |
| Pancrelipase - Creon | AbbVie Inc. | Medical (PDF -566KB) | None | None | PREA |
| Pancrelipase - Pancreaze | Janssen Pharmaceuticals, Inc. | Medical (PDF -142KB) | None | None | PREA |
| Pancrelipase - Pertzye | Digestive Care, Inc. | Medical (PDF - 1MB) | None | None | PREA |
| Pancrelipase - Zenpep | Aptalis Pharma Limited. | Medical (PDF -587KB) | None | None | PREA |
| Paricalcitol - Zemplar | AbbVie Inc. | Medical (PDF - 3.0MB) CDTL (PDF - 1.1MB) |
Clinical pharmacology (PDF - 1.9MB) | Statistical (PDF - 427KB) | PREA |
|
Pegfilgrastim-cbqv - UDENYCA |
Coherus BioSciences, Inc |
Medical (PDF - 228 KB) CDTL (PDF - 584 KB) |
Clinical pharmacology (PDF - 968 KB) | Statistical (PDF - 199 KB) | PREA |
| Peginterferon alfa-2a - Pegays | Hoffmann-La Roche, Incorporated | Medical (PDF - 799 KB) | Clinical pharmacology (PDF - 667 KB) | Statistical (PDF - 667 KB) | PREA |
| Peramivir - Rapivab | BioCryst Pharmaceuticals, Inc. | Medical (PDF - 767KB | Clinical pharmacology (PDF -468 KB) | Statistical (PDF - 767KB) | PREA |
| Peramivir - Rapivab |
BioCryst Pharmaceuticals, Inc. | Medical (PDF - 1 MB | Clinical pharmacology (PDF - 81 KB) | None | PREA |
| Perampanel - Fycompa | Eisai, Inc. | Medical (PDF -4.8MB) | Clinical pharmacology (PDF -6MB) | Statistical (PDF -1.2MB) | PREA |
| Perampanel - Fycompa | Eisai, Inc. | Medical (PDF -2.9MB) Medical (PDF -1.6MB) |
Clinical pharmacology (PDF -4MB) | Statistical (PDF -1.3MB) | PREA |
| Perampanel - Fycompa | Eisai Inc. | Medical (PDF -2.6MB) Medical MTL (PDF -678KB) |
Clinical pharmacology (PDF -1.2MB) | None | PREA |
| Perampanel - Fycompa | Eisai Inc. | Medical (PDF - 79 KB) | Clinical pharmacology (PDF - 86 KB) | None | PREA |
|
Perampanel - Fycompa |
Eisai Inc. |
CDTL (PDF - 452 KB) Medical (PDF - 5 MB)
|
Clinical pharmacology (PDF - 2.5 MB) | None | PREA |
| Phentolamine mesylate - OraVerse | Septodont Holding Sas | Medical (PDF -2.7MB) | None | Statistical (PDF -1.4MB) | PREA |
| Phenylephrine hydrochloride ophthalmic solution | Paragon BioTeck, Inc. | Medical (PDF - 1MB) | Clinical pharmacology (PDF - 95KB) | Statistical (PDF -1MB) | PREA |
| Phenylephrine and ketorolac - Omidria | Omeros Corporation | CDTL (PDF - 1 MB) Medical (PDF - 4 MB) |
None | Statistical (PDF - 816 KB) | BPCA |
| Piperacillin and tazobactam - Zosyn | Wyeth Pharmaceuticals LLC | Medical (PDF - 2 MB) | None | None | PREA |
|
Pitavastatin - Livalo |
Kowa Pharmaceuticals America, Inc. | CDTL Review (PDF - 526 KB) Medical (PDF - 2 MB) |
Clinical pharmacology (PDF - 3 MB) |
Statistical (PDF - 240 KB) | BPCA |
| Pomalidomide - POMALYST | Celgene Corporation | Medical (PDF - 15 KB) | Clinical pharmacology (PDF - 1 MB) | None | BPCA |
| Posaconazole - Noxafil | Merck Sharp & Dohme Corp. | Medical (PDF - 3MB) | Clinical pharmacology (PDF - 1.2MB) | Statistical (PDF - 252KB) | PREA |
| Posaconazole - Noxafil | Merck | Medical (PDF - 602KB) | Clinical pharmacology (PDF - 645KB) | None | PREA |
| Potassium phosphate | Fresenius Kabi USA, LLC | Medical (PDF - 602KB) | None | None | PREA |
| Prasugrel - Effient | Eli Lilly and Company | Medical (PDF - 2MB) | Clinical pharmacology (PDF - 911KB) | Statistical (PDF -290KB) | BPCA |
| Pregabalin - Lyrica | Pfizer | Medical (PDF - 3.8MB) | Clinical pharmacology (PDF - 5.9KB) | Statistical (PDF - 825KB) | PREA |
| Pregabalin - Lyrica | PF PRISM CV | Medical and Statistical (PDF - 1.2 MB) | Clinical pharmacology (PDF - 1.3 MB) | Medical and Statistical (PDF - 1.2 MB) | PREA |
| Pregabalin - Lyrica | Pfizer |
CTDL Review (PDF - 1 MB) Medical (PDF - 1 MB) |
Clinical pharmacology(PDF -1 MB) | Statistical (PDF - 2 MB) | PREA |
| Quetiapine fumarate - Seroquel and Seroquel XR | AstraZeneca Pharmaceuticals LP |
CTDL Review (PDF -1MB) Medical (PDF - 3MB) |
Clinical pharmacology(PDF -1.8MB) Clinical pharmacology (PDF -739KB) |
Statistical (PDF -785KB) | PREA |
| Rabeprazole sodium - AcipHex Sprinkle | Eisa Inc. | Medical (PDF - 3MB) | Clinical pharmacology (PDF - 5MB) | Statistical (PDF 185KB) | BPCA |
|
Ramucirumab - Cyramz |
Eli Lilly and Company | Medical (PDF - 198 KB) | Clinical pharmacology (PDF - 168 KB) | None | BPCA |
| Raltegravir - Isentress | Merck Sharp Dohme Corp | Medical (PDF -1MB) | Clinical pharmacology (PDF -2 MB) | None | PREA |
| Raltegravir - Isentress | Merck Sharp Dohme Corp | CDTL Review (PDF - 4.5 MB) | Clinical pharmacology (PDF - 5 MB) | Statistical (PDF 874 KB) | PREA |
| Raltegravir - Isentress | Merck Sharp Dohme Corp | Medical (PDF - 1 MB) | Clinical pharmacology (PDF - 1 MB) | None | PREA |
|
Ravulizumab-cwvz - Ultomiris |
Alexion Pharmaceuticals, Inc. | Medical (PDF - 5 MB) | None | None | PREA |
| Remdesivir - Veklury | Gilead Sciences, Inc. |
Medical (PDF - 1 MB) Medical (PDF - 776 KB) |
Clinical pharmacology (PDF - 3 MB) |
Statistical (PDF - 225 KB) Statistical (PDF - 782 KB) |
PREA |
| Reslizumab - Cinqair | Teva Respiratory, LLC | Medical (PDF -5MB) | Clinical pharmacology (PDF - 9 MB) | Statistical (PDF -1.6MB) | PREA |
| Rifapentin - Priftin | Sanofi US Services Inc. | Medical (PDF -10.1MB) | Clinical pharmacology (PDF -5.1MB) | Statistical (PDF -3.1MB) | PREA |
| Rilpivirine - Edurant | Janssen Products L.P. | Medical (PDF -2.3MB) | Clinical pharmacology (PDF -138KB) | None | PREA |
| Risperidone - Risperdal Consta | Janssen Pharmaceuticals, Inc. | DD Summary Review (PDF -20KB) CTDL Review (PDF -1MB) Medical (PDF -670KB) Medical (PDF -667KB) |
None | Statistical (PDF -237KB) | PREA |
|
Rituximab-arrx - Riabni |
Amgen, Inc. | Medical (PDF - 7 MB) | None | None | PREA |
| Rufinamide - Banzel | Eisai Inc. | Medical (PDF -9.4MB) | Clinical pharmacology (PDF -3MB) | None | BPCA |
| Ruxolitinib - Jakafi | Incyte Corporation |
Medical (PDF - 685 KB) | Clinical pharmacology (PDF - 533 KB) | None | BPCA |
|
Ruxolitinib - OPZELURA |
Incyte Corporation | Medical (PDF - 9 MB) | None | None | PREA |
| Sacubitril-valsartan - Entresto | Novartis Pharmaceuticals Corp. | Medical (PDF - 685 KB) | Clinical pharmacology (PDF - 533 KB) | Statistical (PDF -1MB) | BPCA |
| Sapropterin dihydrochloride - Kuvan | BioMarin Pharmaceutical Inc. | Medical (PDF -3.6MB) | Clinical pharmacology (PDF -2.5MB) | None | BPCA |
| Saquinavir mesylate - Invirase | Hoffmann La-Roche, Inc.orporated c/o Genentech, Inc. | Medical (PDF -1MB) | Clinical pharmacology (PDF -1.5MB) | Statistical (PDF -1MB) | PREA |
|
Sarecycline - Seysara |
Allergan, Inc. | Medical (PDF -1MB) | None | None | PREA |
| Secnidazole - SOLOSEC | Lupin Pharmaceuticals, Inc. | Medical (PDF 4 1MB) | None | None | PREA |
|
Secukinuma - Cosentyx |
Novartis Pharmaceuticals Corporation | Medical (PDF - 6 MB) | None | None | PREA |
| Selegiline - Emsam | Somerset Pharmaceuticals | Medical (PDF -1.1MB) Medical 2 (PDF -1.2MB) Medical Secondary 1 (PDF -349KB) Medical Secondary 2 (PDF -188KB) |
None | None | PREA |
| Selenious Acid - Selenious Acid | American Regent, Inc. | Medical (PDF - 8 MB) | None | None | PREA |
| Segesterone acetate and ethinyl estradiol vaginal systems - Annovera | The Population Council, Inc. | Medical (PDF - 5 MB) | None | None | PREA |
| Serdexmethylphenidate chloride (SDX Cl) & Dexmethylphenidate hydrochloride (d-MPH HCL) - Azstarys | Commave Therapeutics SA | Multidisciplinary (PDF - 6 MB) | None | None | PREA |
| Sevelamer Carbonate - Renvela | Genzyme/Sanofi | Medical (PDF - 745KB) | Clinical pharmacology (PDF - 542KB) | Statistical (PDF - 541KB) | PREA |
|
Sitagliptin - Januvia, Janumet & Janumet XR
|
Merck Sharp & Dohme Corp.: |
CDTL (PDF - 1 MB) Medical (PDF - 4 MB) |
Clinical pharmacology (PDF - 339 KB) | Statistical (PDF - 623 KB) | BOTH |
| Sildenafil - Revatio | Pfizer, Inc. | Medical (PDF - 6MB) | Clinical pharmacology (PDF -2MB) | Statistical (PDF -508KB) | BOTH |
| Sodium picosulfate, magnesium oxide, and anhydrous citric acid - Prepopik | Ferring Pharmaceuticals Inc. | Medical (PDF - 193 KB) | None | None | PREA |
| Sodium sulfate, potassium sulfate, and magnesium sulfate - Suprep Bowel Prep Kit | Sponsor: Braintree Laboratories, Inc. |
Medical (PDF - 193 KB) |
None | None | PREA |
|
Sodium picosulfate, magnesium oxide and anhydrous citric acid - Clenpiq |
Ferring Pharmaceuticals Inc. |
CDTL (PDF - 1 MB) | None | None | PREA |
| Spinosad - Natroba | ParaPRO, LLC | Medical (PDF - 854KB) | Clinical pharmacology (PDF -171KB) | None | PREA |
| Sofosbuvir - Sovaldi | Gilead Sciences, Inc. | Medical and CDTL (PDF - 345 KB) | Clinical pharmacology (PDF - 511 KB) | None | PREA |
| Sofosbuvir - Sovaldi | Gilead Sciences, Inc. | Medical (PDF - 218 K) | None | None | PREA |
| Sofosbuvir and velpatasvir - Epclusa | Gilead Sciences, Inc. | Medical (PDF - 218 K) | Clinical pharmacology (PDF - 511 KB) | None | PREA |
| Sofosbuvir and velpatasvir - Epclusa | Gilead Sciences, Inc. | Medical (PDF - 287 KB) | Clinical pharmacology (PDF - 4 MB) | None | BPCA |
| Solifenacin succinate - VESIcare | Astellas Pharma Global Development, Inc. | Medical (PDF - 2 MB) | Clinical pharmacology (PDF - 933KB) | Statistical (PDF - 960 KB) | PREA |
| Solifenacin succinate - VESIcare | Astellas Pharma Global Development, Inc. | Medical (PDF - 3MB) CDTL (PDF - 1.1MB) |
Clinical pharmacology (PDF -2MB) | Statistical (PDF - 960 KB) | PREA |
| Spinosad - Natroba | ParaPRO LLC | Medical (PDF - 458 KB) | None | None | PREA |
| Sulfur Hexafluoride Lipid-Type A Microspheres) for Injectable Suspension - Lumason | Bracco Diagnostics Inc. | Medical (PDF - 5.1MB) | Clinical pharmacology (PDF -2MB) | Statistical (PDF -792KB) | PREA |
| Sulfur Hexafluoride Lipid-Type A Microspheres - Lumason | Bracco Diagnostics, Inc. | Medical (PDF - 3MB) CDTL (PDF - 1.1MB) |
Clinical pharmacology (PDF - 1MB) | Statistical (PDF - 859KB) | PREA |
| Sulfur Hexafluoride Lipid-Type A Microspheres - Lumason | Bracco Diagnostics, Inc. | Medical (PDF -1.8MB) | Clinical pharmacology (PDF -2.8MB) | Statistical (PDF -843KB) | PREA |
| Sugammadex - Bridion |
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. | Medical (PDF - 3 MB | Clinical pharmacology (PDF - 2 MB) |
Statistical (PDF - 2 MB) | BPCA |
| Sumatriptan/Naproxen - Treximet | Pernix Therapeutics | Medical (PDF -1.8MB) | Clinical pharmacology (PDF -2.8MB) | Statistical (PDF -843KB) Statistical Addendum (PDF -702KB) |
BPCA |
| Sunitinib malate - Sutent | C.P. Pharmaceuticals International C.V. | CDTL (PDF - 680 KB) | None | None | PREA |
| Tacrolimus - Astagraf XL |
Astellas Pharma US, Inc.
|
Medical (PDF - 749 KB) | None | None | PREA |
| Tadalafil - Cialis | Eli Lilly and Company | Medical (PDF - 1 MB) | Clinical pharmacology (PDF - 1.4MB) | None | BPCA |
| Tavaborole - Kerydin | Anacor Pharmaceuticals, Inc. | Multi-disciplinary review (PDF - 2.5 MB) | None | None | PREA |
| Tazarotene - Aralzo | Bausch Health US, LLC | Clinical (PDF - 1 MB) | None | None | PREA |
| Tbo-filgrastim - Granix | Sicor Biotech UAB c/o Teva Branded Pharmaceutical Products R&D |
CDTL (PDF - 176 KB) Clinical (PDF - 196 KB) |
Clinical pharmacology (PDF - 434 KB) | None | BPCA |
| Technetium 99m Tilmanocept - Lymphoseek | Cardinal Health 414, LLC | Multidisciplinary (PDF - 2.2MB) | None | None | PREA |
| Tedizolid phosphate - Sivextro | Cubist Pharmaceuticals, LLC | Medical (PDF - 9 MB) | None | None | PREA |
| Teduglutide - Gattex | Shire-NPS Pharmaceuticals, Inc. | Medical (PDF - 9 MB) | None | None | BOTH |
| Tenofovir disoproxil fumarate - Viread | Gilead Sciences | Medical (PDF - 2.4MB) | Clinical pharmacology (PDF - 1.4MB) | Statistical (PDF - 1.4MB) | PREA |
| Tenofovir disoproxil fumarate - Viread | Gilead Sciences | CDTL (PDF - 873 KB) | Clinical pharmacology (PDF - 180 KB) | Statistical (PDF - 149 KB) | PREA |
| Tenofovir disoproxil fumarate - Viread | Gilead Sciences | CDTL (PDF - 349 KB) | Clinical pharmacology (PDF - 1.7 MB) | Statistical (PDF - 148 KB) | PREA |
| Teriflunomide - Aubagio | Sanofi |
CTDL (PDF - 3.3MB) Clinical (PDF - 3.4MB) |
Clinical pharmacology (PDF - 1.5MB) | Statistical (PDF - 410KB) | BOTH |
| Tetracaine hydrochloride - None | Alcon Research, Ltd. | DD Medical Summary (PDF -1.8MB) Medical (PDF -1.4MB) |
Clinical pharmacology (PDF - 158KB) | Statistical (PDF - 2.3MB) | PREA |
| Tetracaine HCl and Oxymetazoline HCl - Kovanaze | St. Renatus, LLC | Medical (PDF - 11.8MB) | Clinical pharmacology (PDF - 11.6MB) | Statistical (PDF - 2.4MB) | PREA |
|
Tezepelumab -Tezspir |
AstraZeneca | Medical (PDF - 10 MB) | None | None | PREA |
| Tilmanocept - Lymphoseek |
Cardinal Health 414, LLC | Medical (PDF - 2 MB) | None | None | PREA |
| Tiotropium bromide - Spiriva Respimat | Boehringer Ingelheim Pharmaceuticals, Inc. | Medical (PDF -11.9MB) Medical Addendum (PDF - 418KB |
Clinical pharmacology (PDF - 5.9MB) | Statistical (PDF - 1.3MB) Statistical Addendum (PDF -327 KB) |
PREA |
| Tiotropium bromide - Spiriva Respimat | Boehringer Ingelheim Pharmaceuticals, Inc. | Medical (PDF - 4.8MB) | Clinical pharmacology (PDF - 2MB) | Statistical (PDF - 432K B) | PREA |
| Tobramycin 300 mg/4mL inhalation solution - Bethkis | Cornerstone Therapeutics | Medical (PDF - 5.4MB) | Clinical pharmacology (PDF - 78KB) | Statistical (PDF - 687 KB) | PREA |
|
Tocilizumab - Actemra |
Genentech, Inc. |
Medical (PDF - 72 KB) Medical (PDF - 109 KB) |
Clinical pharmacology (PDF - 195 KB) | None | PREA |
|
Tocilizumab - Actemra
|
Genentech, Inc. | Medical (PDF - 8 MB) | None | None | PREA |
| Tofacitinib - Xeljanz | Pfizer, Inc. | Medical (PDF - 8 MB) | None | None | PREA |
| Topiramate - Topamax | Janssen Pharmaceuticals, Inc. | Medical (PDF - 8.6MB) | None | Statistical (PDF - 881KB) | PREA |
|
Topiramate - Eprontia |
Azurity Pharmaceuticals, Inc. | Medical (PDF - 669 KB) | Clinical pharmacology (PDF - 565 KB) | None | PREA |
| Trabectedin - Yondelis | Janssen Products, LP | Medical (PDF - 2.5 MB) | Clinical pharmacology (PDF - 683 KB) | None | BPCA |
| Trace elements injection 4 - Tralement | American Regent, Inc. | Medical (PDF - 2.5 MB) | None | None | PREA |
| Trace elements injection 4 - Multrys | American Regent, Inc. | Medical (PDF - 321 MB) | None | None | PREA |
| Tranexamic acid - Lysteda | Ferring Pharmaceuticals, Inc. | None | Clinical pharmacology (PDF - 1.2MB) | None | PREA |
| Tretinoin lotion - Altreno | Dow Pharmaceutical Sciences, Inc. | Medical (PDF - 3 MB) | None | None | PREA |
| Tretinoin and benzoyl peroxide - Twyneo | Sol-Gel Technologies Ltd. c/o B&H Consulting Services Inc. | Medical (PDF - 2 MB) | None | None | PREA |
| Trifarotene - Akli | Galderma Research and Development, LLC | Medical (PDF - 3 MB) | None | None | PREA |
| Upadacitinib - Rinvoq NEW | AbbVie Inc. | Medical (PDF - 10 MB) | None | None | PREA |
| Ustekinumab - Stelara | Janssen Biotech, Inc. | Medical (PDF - 352 MB) | Clinical pharmacology (PDF - 3 MB) | None | PREA |
| Valganciclovir hydrochloride - Valcyte | Roche Palo Alto LLC c/o Genentech, Inc.orporated | Medical (PDF -2 .7MB) | Clinical pharmacology (PDF - 6MB) | None | PREA |
|
Valsartan - Diovan |
Novartis Pharmaceuticals Corporation | Medical (PDF - 2 MB) | None | None | PREA |
|
Varenicline - Chantix
|
PF Prism C V | None | Clinical pharmacology (PDF - 3 MB) | None | PREA |
| Vilazodone hydrochloride - Viibryd | Allergan Sales, LLC | Medical (PDF - 3 MB) | None | None | BPCA |
|
Vortioxetine - Trintellix |
Takeda Pharmaceuticals, USA, Inc. | Medical (PDF - 3 MB) | None | None | PREA |
| Ustekinumab - Stelara | Janssen Biotech Inc. |
CDTL (PDF - 593 KB) Medical (PDF - 5.2 MB) |
Clinical pharmacology (PDF - 3 MB) | Statistical (PDF - 275 KB) | PREA |
| Vigabatrin - Sabril | Lundbeck LLC. | Medical (PDF - 4MB) | Clinical pharmacology (PDF - 2.3MB) | Statistical (PDF - 698KB) | BOTH |
| Viloxazine extended release capsules - Qelbree |
Supernus Pharmaceuticals, Inc. |
Medical (PDF - 13 KB) Medical (PDF - 13 MB) |
None | None | PREA |
| Voriconazole - Vfend | PF PRISM C.V. |
Medical (PDF - 2 MB) Medical PDF - 200 KB) |
Clinical Pharmacology (PDF - 1 MB) | Statistical (PDF - 200 KB) | PREA |
| Zepatier (elbasvir and grazoprevir) | Merck Sharpe & Dohme Corp | Medical (PDF - 838 KB) | Clinical Pharmacology (PDF - 272 KB) | PREA | |
| Zinc sulfate - None | American Regent, Inc. | Medical (PDF - 4 MB) | None | None | PREA |
| Zolmitriptan - Zomig | AstraZeneca Pharmaceuticals LP | Medical (PDF -4.5MB) | None | Statistical (PDF -2.9MB) | PREA |